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U.S. Department of Health and Human Services

Class 2 Device Recall ED PulseCheck

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  Class 2 Device Recall ED PulseCheck see related information
Date Initiated by Firm June 21, 2013
Date Posted July 29, 2013
Recall Status1 Terminated 3 on December 19, 2014
Recall Number Z-1814-2013
Recall Event ID 65666
Product Classification Software, transmission & storage, patient data - Product Code NSX
Product Picis ED Pulsecheck - EMR Software Application - 2125, Software Versions: 5.2 and 5.3. The application stores patient information in a database, and it may analyze and/or display the data in different formats for evaluation by healthcare professionals for informational purposes.
Code Information Software Versions 5.2 and 5.3
Recalling Firm/
Picis Inc.
100 Quannapowitt Parkway
Suite 405
Wakefield MA 01880
For Additional Information Contact Support Representative
Manufacturer Reason
for Recall
Notes associated with prescription are not printed to the prescription or to the patient chart.
FDA Determined
Cause 2
Software change control
Action Initial customer notifications were sent via email on June 21, 2013 informing consignees of the recall and providing further instruction regarding the software solution. Consignees were provided with recommended actions until they receive the necessary update.
Quantity in Commerce 35
Distribution Nationwide Distribution, including the states of: AK, AR, AZ, CA, CO, DC, DE, FL, GA, ID, IN, MA, MD, MO, NH, NJ, OH, OR, SC, TN, WA, and WV.

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.